U.S. Commercialization Committee Sample Clauses

U.S. Commercialization Committee. If Infinity exercises its Co-Detailing Rights and Infinity and the appropriate Novartis Affiliate enter into a Co-Detailing Agreement with respect to a Licensed Product, Infinity shall be entitled to have up to one (1) representative sit on the U.S. commercialization committee established by Novartis (“U.S. Commercialization Committee”) for such Licensed Product when such committee is established. The U.S. Commercialization Committee shall have responsibility for general oversight of all commercialization activities (including promotion and Detailing) with respect to such Licensed Product in the United States. In the event of a dispute between the Parties at the U.S. Commercialization Committee (or in connection with any other commercialization dispute between the Parties), then the dispute shall be referred to the Executive Officers (which, in the case of Novartis shall be the President of the Novartis Oncology Business Unit or his or her designee) for good faith resolution. In the event that the dispute is not resolved, Novartis shall have the deciding vote. No such decisions shall obligate Infinity to spend money or devote resources outside those previously agreed to in this Agreement or the mutually-agreed Co-Detailing Agreement, in no event may Novartis amend the terms of this Agreement or the Co-Detailing agreement and in no event may Novartis unilaterally determine that it has fulfilled any obligations hereunder or thereunder or that Infinity has breached any obligations hereunder or thereunder.
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U.S. Commercialization Committee. [***] Legend and Xxxxxxx shall establish a U.S. commercialization committee (the “USCC”), which shall report to the JSC and shall (i) oversee and make decisions with respect to the Parties’ Commercialization of the Products in the Field in the U.S. pursuant to this Agreement, to the extent provided in ARTICLE V, and (ii) perform the other functions that are expressly delegated to the USCC in this Agreement. The USCC shall include individuals from each Party with reasonable expertise in the areas of finance, operations, sales and marketing. If this Agreement requires that any decision be made by the USCC before it is formed, such decision shall be made by the JSC.
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U.S. Commercialization Committee. At a time agreed by the Parties but no less than [...***...] in advance of the first anticipated Marketing Approval of a Licensed Product in the U.S., argenx and Xxxxxxx shall establish a U.S. commercialization committee (the “USCC”) which shall: (i) oversee and make decisions with respect to the Parties’ Commercialization of the Licensed Products in the U.S. pursuant to this Agreement, to the extent provided in Article VI; and (ii) perform the other functions that are expressly delegated to the USCC in this Agreement. The USCC shall include individuals from each Party with reasonable expertise in the areas of finance, operations, sales and marketing. If this Agreement requires that any decision be made by the USCC before it is formed, such decision shall be made by the JSC.
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U.S. Commercialization Committee. If SGX exercises its Co-Commercialization Rights and the Parties enter into a Co-Commercialization Agreement with respect to a Product, SGX shall be entitled to have up to [***] representative sit on the US and Canada commercialization committee established by Novartis for such Product (“US Commercialization Committee” or “UCC”). The UCC shall be established no later than thirty (30) days following the exercise by SGX of its Co-Commercialization Rights. The UCC shall have responsibility for general oversight of all commercialization activities (including promotion and Detailing) with respect to such Product in the Co-Commercialization Territory, including preparing and approving a Marketing Plan for the Co-Commercialization Territory and will give good faith consideration to SGX’s position in making decisions regarding commercialization planning and strategy. In the event of a dispute between the Parties at the UCC, then the dispute shall be referred to the Senior Officers for good faith resolution. In the event that the dispute is not resolved, Novartis shall have the deciding vote.
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U.S. Commercialization Committee 
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Related to U.S. Commercialization Committee

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of up to [**] representatives of Verve and up to [**] representatives of Acuitas (the “JDC”). One such representative from each Party will be such Party’s Workplan Leader. Each Party may replace its Workplan Leader and other JDC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts to ensure continuity on the JDC. With the consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), each Party may invite non-voting employees and consultants to attend JDC meetings, subject to their agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Steering Committee The Project Manager shall set up a Steering Committee for the Project, consisting of representatives from the Department, the Contractor, and any other key organisations whom the project will impact on, to be agreed between the parties. The function of the Steering Committee shall be to review the scope and direction of the Project against its aims and objectives, monitor progress and efficiency, and assess, manage and review expected impact and use of the findings from the Project. The Committee shall meet at times and dates agreed by the parties, or in the absence of agreement, specified by the Department. The Contractor’s representatives on the Steering Committee shall report their views on the progress of the Project to the Steering Committee in writing if requested by the Department. The Contractor’s representatives on the Steering Committee shall attend all meetings of the Steering Committee unless otherwise agreed by the Department.

  • TRANSITION COMMITTEE 8.1.0 A transition committee comprised of the employee representatives and the employer representatives, including the Crown, will be established by January 31, 2016 to address all matters that may arise in the creation of the Trust.

  • Joint Development Committee The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Merck and BioLineRx, which shall have responsibility of coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of information between the Parties, with respect to the Study. Other JDC members will be agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the BioLineRx Project Manager shall provide an update in writing to the Merck Project Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed, and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRx.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Joint Steering Committee [***] following the Effective Date [***], a joint steering committee (the “JSC”) will be established by the Parties to provide oversight and to facilitate information sharing between the Parties with respect to the activities under this Agreement.

  • Joint Job Evaluation Committee The parties entered into agreement December 17, 1992, to ensure the Joint Gender- Neutral Job Evaluation Plan remains current and operational and to that end endorsed the Joint Gender-Neutral Job Evaluation Maintenance Agreement. The parties agree that a guiding principle for the Committee is that there shall be no discrimination between male and female employees wherein a person of one sex is paid more than a person of the other sex for similar or substantially similar work.

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